Phase III Study Comparing Induction Chemotherapy Followed by Radiotherapy Alone or Combined with Concurrent Chemotherapy in Advanced Nasopharyngeal Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with locoregionally advanced nasopharyngeal carcinoma NPC, a type of cancer affecting the nasopharynx. This study aims to compare two treatment approaches during the era of intensity-modulated radiation therapy IMRT, which has improved local control of the disease. It focuses on whether adding induction chemotherapy IC followed by radiotherapy alone can reduce toxic side effects compared to combining IC with concurrent chemoradiotherapy CCRT. Participants will be randomly assigned to one of two groups. One group receives induction chemotherapy with gemcitabine and cisplatin every three weeks for three cycles, followed by IMRT combined with concurrent cisplatin chemotherapy. The other group receives the same induction chemotherapy followed by IMRT alone without concurrent chemotherapy. IMRT is given five days a week for 6 to 7 weeks with specific radiation doses targeted to the tumor and nearby lymph nodes. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor the cancers response and side effects. The main outcome measured is progression-free survival over three years. Other outcomes include overall survival, failure-free survival rates, response rates, and adverse events. The study monitors treatment effects and safety throughout, with follow-up lasting at least three years after treatment.

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma